OPTIPRED EYE DROPS 5ML

Indications

Approved Uses

Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye (including inflammation due to allergies, chemicals, heat, radiation, or foreign bodies), and postoperative ocular inflammation.

Dosage & Administration

Dosing by Condition

Ocular inflammation (general): 1-2 drops in the affected eye(s) 2-4 times daily; in the first 24-48 hours, dosing may be increased up to every hour if needed, then taper as response occurs (severe anterior uveitis may require very frequent initial dosing under ophthalmologist supervision).

Initial Dose

One to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.

Maximum Dose

One to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.

Children's Dosage

Use with caution in children; same dosing as adults under ophthalmologist supervision. Safety and efficacy in neonates not established

Dose Adjustment Notes

Taper frequency gradually as inflammation improves; avoid prolonged/high-frequency use without ophthalmic reassessment, and check IOP if treatment continues for ≥10 days.

How to Prepare

Shake well before each use to resuspend the ophthalmic suspension uniformly.

Side Effects

Common Side Effects

Transient burning/stinging/irritation and temporary blurred vision; with continued/prolonged use: increased intraocular pressure and risk of cataract, delayed wound healing, and increased risk of ocular infection.

Side Effect Frequency

Common: transient burning/stinging/irritation and temporary blurred vision after instillation. Less common/with prolonged use: increased intraocular pressure/glaucoma, delayed wound healing, posterior subcapsular cataract, secondary ocular infection (including viral/fungal), and corneal/scleral thinning/perforation in predisposed patients.

Safety & Warnings

Contraindications

Contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea/conjunctiva; mycobacterial ocular infection; fungal diseases of ocular structures; hypersensitivity to prednisolone/components.

Warnings & Precautions

If used ≥10 days, monitor intraocular pressure; prolonged use increases risk of glaucoma/optic nerve damage and posterior subcapsular cataract; may mask/worsen infection and increase risk of secondary infection; use caution with corneal/scleral thinning; avoid contact lenses during instillation and reinsert after ~15 minutes if applicable; re-examine frequently during prolonged therapy.

Age Restriction

No specific minimum age in labeling; pediatric use only under ophthalmologist supervision (use the lowest effective dose and monitor IOP with prolonged therapy).

Special Populations

Children

Use with caution in children; same dosing as adults under ophthalmologist supervision. Safety and efficacy in neonates not established

Kidney Impairment

No dose adjustment needed for renal impairment (ophthalmic use).

Storage & Patient Advice

Preparation Instructions

Shake well before each use to resuspend the ophthalmic suspension uniformly.

Stopping the Medicine

Do not stop abruptly after prolonged/frequent use; taper as directed to prevent rebound inflammation.

Monitoring Requirements

Monitor intraocular pressure if used for ≥10 days; with prolonged/repeated courses, perform ophthalmic examination (e.g., slit-lamp) to assess for cataract, infection, and corneal thinning/healing problems.

Pharmacology

Mechanism of Action

Binds intracellular glucocorticoid receptors to alter gene transcription, inducing lipocortins that inhibit phospholipase A2 and reducing prostaglandin/leukotriene production; decreases capillary permeability and leukocyte migration to suppress ocular inflammation.

Product Information

Available Dosage Forms

For this product: Eye drops, suspension (ophthalmic suspension) 5 mL dropper container.

Composition per Dose

Each 1 mL of suspension: Prednisolone acetate 10 mg (1%)

Generic Availability

Yes

OTC Alternatives

No OTC alternative for prescription ophthalmic corticosteroids; OTC lubricating eye drops for symptomatic relief only

Target Organ

Eye

Preservative Free

No

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